American Methadone Treatment Association,

American
Methadone
Treatment
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Maryland
Massachusetts
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217 Brmrciway
20003
,.,
October 27,
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999
NwYorh,NY
Phone: (2 12) 566-5555
Fax: (2 12) 349-29-M
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BOARD OF DIRECTORS..
M.P.A
Mark W.. Parnno,
President
Dockets Management Branch
(HFA - 305)
Food and Drug Administration
5630 Fishers Lane (Room 1061)
Rockville, MD 20857
Robert Holden, C.C.D.T.
Vice Prexident
Washjngtms,D.C.
Craig S. Stenning,
Treasurer
Rhode Island
[Docket No. 98N-0617]
To Whom It May Concern:
M.P..4.
Carol B. Butler, N.C.A.C. I
Secretary
Maryland
BOARD MEMBERS
Emizie Abbott, C.C.D.C. 111.
Ohio
Richard Bilangi, M.S.
Connecticut
Anthony C. Clemente, C.S.W.
Michigan
Bruce B. Douglas, C.A.S.
Pennsylvania
Edward J. Higgins, M.A.
New Jersey
Alex John, Jr. , Ed.D
Texas
~
Robert Kahn, Ph.D.
r_—..
‘Califimla
Janice F. Kauffman, R.N.
Massachusetts
Andrea Barthwell,
M.D.
fflinois
Peter Coleman, M.A.
New York
Paul McLaughlin, ?WA.
Connecticut
J. Thomas Payte, M.D.
AmericanSoeictyof
AddictionMedtcine
Michael A. Rizzi
Rhode k+land
Onaje M. Salim,
N. C.A.C.
n.
I am writing in response to the Federal Register Notice of July 22, 1999,
setting forth proposed rules to repeal the existing Narcotic Treatment
Regulations as enforced by the Food and Drug Administration, in addition
to creating a new regulatory system founded on the principles of an
accreditation model.
The American Methadone Treatment Association represents 643
methadone programs throughout the United States or 810/0of the nation’s
methadone treatment services for 151,329 patients through the organizing
vehicle of State Methadone Provider Associations. The Association has
continually demonstrated its commitment to improve treatment practices
through the development of national conferences, regionalized symposia
and the publication of treatment standards and guidelines.
The Association has convened regional conferences since 1984, which
evolved into national events during 1990. Regional symposia have
focused on managed care interventions, management training practices
and physician education seminars. The physician training opportunities
have been offered in conjunction with the American Society of Addiction
Medicine and more recently with the American Academy of Addiction
Psychiatry. Future training opportunities will also include the American
Osteopathic Academy of Addiction Medicine.
The American Methadone Treatment Association developed State
Methadone Treatment Guidelines for the Center for Substance Abuse
Georgia
Keith E. Spare, M.S.
Missouri
George E. Stavros,
Arizona “
Gary Wenner
Florida
SouthCarolina
M.D.
9&kkxi’i7
Suite 304
10007
Treatment in 1992 in conjunction with the Methadone Treatment
Committee of the American Society of Addiction Medicine.
The Association has been working with the Drug Enforcement
Administration to produce a series of guidelines, which will improve the
accountability and tracking of methadone hydrochloride products at the
program setting. All of these endeavors work to enhance the quality of
care in the nation’s treatment system.
Support for an Accreditation
Based System
The Association’s support for the development of standardized outcome
measures in evaluating the efficacy of methadone “treatment can be traced
back to the development of the State Methadone Treatment Guidelines.
These Guidelines were developed following the publication of several
critical reports on the effectiveness of methadone treatment in the United
States.
The final report of the White House Conference for A Drug Free America,
which was published in June, 1988, indicated that “measuring the success
of a treatment program is complicated because drug addiction is a chronic
disorder that may require numerous treatment episodes and relapse can be
one step back on the road to long term recovery. Despite the difficulties,
standardized, objective measures that recognize the differences inherent in
each type of treatment modality must be developed.”
The introduction to the State Methadone Treatment Guidelines provided
the illustration of a patient embarking on a cross country trip, receiving
varying degrees of medical care depending on the program or state he or
she happened to be traveling through during the journey. “This traveling
patient might find himself or herself in a ‘low dose’ state or a state that
ties the amount of take home methadone medication to the dosage level.
Treatment providers and policy officials should be careful to avoid
dysft.mctional practices in treating opioid dependent individuals if they
want treatment to be effective. ”
The Association’s support for accreditation in evaluating the effectiveness
of methadone treatment is rooted in the fact that a major segment of the
healthcare system in the United States is being reviewed through such
accreditation standards. We believe that accrediting methadone treatment
will offer the potential of embracing methadone treatment as part of
mainstream medicine in the United States. We understand that the
elements of such accreditation standards will draw upon the principles of
the aforementioned State Methadone Treatment Guidelines, fulfilling the
promise of ensuring that patients will be able to access a reliable standard
2
of care, regardless of the size and location of a particular program or state
policy.
The Association supported the implementation of the accreditation pilot
project to incorporate 180 programs in the study, which is taking place in
fitleen states. We are hopeful that the pilot will yield valuable information
to guide federal agencies in developing a Final Rule, which will lead to the
broad implementation of an accreditation system for methadone treatment
throughout the United States.
It is critical that credible data are used to develop a blueprint to execute
such a major transition in regulatory oversight. We anticipate that this
transition will be more costly than the federal agencies have anticipated,
based on the data contained in the federal register notice of July 22, 1999.
We have attached reports from methadone program administrators in
different states, underscoring such concerns, especially as they relate to
the indirect costs of implementing accreditation standards in their
respective treatment programs.
The Association is also concerned about the duplication of regulatory
oversight, which creates conflict and incurs significant expense. It is
hoped that one uniform standard will be adopted and implemented in
accordance with recommendations from the Institute of Medicine and
federal agencies. The following comments detail the Association’s
response to the Notice for Proposed Rule Making.
Analysis of Impacts
Section VIII (C) of the NPRM provides a baseline description of the
treatment system. It indicates that the FDA has approved 869 methadone
treatment programs as of early 1997, which encompass outpatient
maintenance programs exclusively. Our Association recently conducted a
survey of methadone treatment programs in the 42 states and the District
of Columbia and found that 785 treatment programs were in existence.
We realize that this number did not incorporate a number of VA
methadone treatment programs, which would have increased the total.
The NPRM also indicated that the Secretary “estimates the total census of
patients in opioid treatment to be approximately 125,000.” The
Association’s 1998 survey data indicated that approximately 179,000
people were in treatment throughout the United States.
The Association has reviewed federal agency reports, indicating that more
than 800,000 individuals are dependent on opiates throughout the United
States (ONDCP – March, 1999). We understand that the intent of the
3
Proposed Rule is also to increase access to care through the vehicle of
accreditation.
It is certainly possible, that treatment will be made more available to
people in need of care through the vehicle of accreditation, however,
without an infusion of significant funds at the federal level, meaningful
treatment expansion will not occur, Accreditation alone cannot be
expected to increase access to care unless there is a commitment of funds
to educate the public about the value of methadone treatment and to
increase access to new treatment sites.
Costs of the Proposed Regulation
Section VIII (E) discusses the cost of the proposed regulations. It presents
information about the direct costs of becoming accredited in addition to
indirect costs of improving program procedures to meet accreditation
standards.
This section also amortizes the one time cost of accreditation over a three
year period of time. This represents a contrivance since the program will
incur accreditation costs immediately, which cannot be amortized over
three years. The Rule assumes that the majority of programs will on]y be
accredited at three year intervals, in spite of the fact that the Secretary
does not have supporting data to substantiate this perspective.
It appears that the direct cost of accrediting a methadone treatment
program ranges from $7,500.00-$11,000.00
(refer to Appendix A, which
provides additional information).
The NPRM also indicates: “the most costly compliance activities would be
for OTPS that currently do not offer one of the identified services. In
order to continue operations, these facilities would be required to offer
these services, and incur costs of $150.00 per patient or$21,000.00.”
Once again, these figures are based on the average census numbers for the
program within the scope of the NPRM’s paradigm. A review of
Appendix A indicates that a number of currently accredited methadone
programs have incurred significant staff costs in preparing for
accreditation surveys and implementing post survey improvements to be
in compliance with accreditation standards, Unfortunately, all of the
reporting programs were not able to accurately capture the indirect staff
costs, which were incurred in preparing for accreditation surveys.
Three of the reporting states, which were listed in Appendix A, indicate
significant indirect costs. Illustratively, the Missouri based methadone
program reported a $35,000.00 expenditure for staff time, computer
upgrade and physical plant improvement. The Rhode Island program
.
incurred expenses in the amount of $26,916.00, including the development
of an infectious control manual and the hiring of a mental health
consultant. The Texas based program reported an indirect cost in the
amount of $45,000.00, which is related to the retention of a full time
psychologist.
It is hoped that the fiscal data, which will result from the accreditation
pilot study, will yield accurate information prior to the full-scale
implementation of accreditation in methadone maintenance treatment.
Recommendation
to Establish a Federal Fund
Our Association is urging the federal government to develop a multiyear,
multipurpose fund to ensure that methadone treatment programs and
patients will not be adversely affected by the implementation of
accreditation standards, ultimately, decreasing access to care through
program closure.
This find may be developed on a needs based model, which would pay for
the cost of submitting the accreditation application (CARF only) in
addition to the cost of the survey. The fund would also provide financial
and technical support in implementing improvements as a result of the
accreditation survey, which would include training of personnel,
implementing new information management systems and executing
physical plant improvements. The Association recommends that the
results of the pilot project be used as a basis in developing such a federal
fund. If such a fund is not established, access to care will be affected as
programs close under the weight of excessive fiscal burdens. Appendix A
indicates that the indirect costs of implementing accreditation are
considerable.
The Role of the FDA and the States
Section II (B) of the Rules discusses current oversight of the methadone
treatment system. It indicates that “the frequency with which FDA
conducts routine inspections has been steadily decreasing as FDA
continues to focus on its other core priorities.” The FDA was criticized
for lack of regulatory vigilance in the General Accounting Office Report
of 1990. Many treatment programs in a number of states have not been
inspected by the FDA for more than ten years. The concept of regulatory
triage has been cited at different times in how the FDA has approached its
inspection schedule. Unfortunately, the only method of conducting true
regulatory triage, as it has been conceived, is to have an overview of
program deficiencies. The FDA is not in such a position.
5
The Association conducted a survey of the State Methadone Authorities
following the release of the Proposed Rule. The results of this survey are
summarized in Appendix B. Six states have indicated that twenty-one
treatment programs are currently in violation of FDA regulations. Ten
states have reported that forty-five programs are in violation of current
state regulations. Five states have indicated that five programs are in
danger of closing. Twenty-nine states have indicated that 155 programs
need programmatic technical assistance. Sixteen states have indicated that
twenty-five programs need physical plant improvements. Twenty-one
states rated 172 programs as excellent. Thirty states rated 209 programs
as good. Twenty-five states have rated 145 programs as fair and eleven
states rated 36 programs as poor.
The findings from the states are significant in providing direction to the
federal government concerning the challenges of changing to accreditation
based outcome oriented oversight. The federal agencies, which will be
responsible for implementing accreditation standards, must be mindful of
the challenges to the treatment system in executing such sweeping
changes.
The role of the FDA must be clearly communicated to the states and to
treatment programs during the accreditation pilot, providing guidance
leading to the full-scale implementation of accreditation, once the results
of the pilot have been fully evaluated.
Will the FDA continue to be involved in conducting “for cause”
inspections of methadone treatment programs? If the FDA is expected to
conduct such “for cause” inspections, has the Secretary developed a
realistic budget to implement such a policy? How will the FDA determine
if such “for cause” inspections are needed? How will the FDA work in
conjunction with CSAT in conducting “for cause” inspections? How will
the FDA work in conjunction with State Methadone Authorities in
conducting such inspections? Clearly, such questions are beyond the
scope of our Association and have not been incorporated in the Notice for
Proposed Rule Making.
Role of the States
Individual states have promulgated regulations, governing the practices of
methadone programs in their respective jurisdictions. In certain states,
such regulatory oversight has been executed to compensate for the dearth
of FDA oversight. In other states, the specific interests of elected and
appointed officials have been taken into account. Eight states still do not
have any methadone maintenance treatment programs, with Wyoming
being the most recent state to close its small treatment program (serving
three patients) during February, 1999 and New Hampshire as the most
.
6
.—
.
recent state to open a 180 day outpatient methadone to abstinence
program.
Section II (C) (3) discusses the role of the State Authority. “State
Authorities may choose to apply to act as accreditation bodies for
programs in their jurisdiction and, if approved, would consolidate
inspections and minimize burdens. Alternatively, State Authorities could
adopt accreditation body findings.”
Recommendations to Work with the States in Developing
a Uniform Accreditation System
The Association recommends that the federal agencies, which are
responsible for implementing accreditation, work in conjunction with the
State Authorities to maximize the use of one accreditation standard. We
realize that several entities may be involved in conducting such
accreditation reviews. We urge the federal government not to approve an
excessive number of entities to be involved in conducting such
accreditation, since it would run counter to the intent of developing a
stable oversight mechanism. The greater number of entities, which would
be involved in conducting accreditation surveys, will also produce greater
variation in the standards of care.
The Association is hopeful that states will adopt accreditation body
findings once it is determined that the accreditation surveys are responding
to the needs of the states in ensuring that good quality care is being
provided within the methadone treatment programs. We have been
informed by a number of State Authorities that they would not be willing
to adopt accreditation body findings in lieu of their own state inspections.
Recommendations
for Office Based Methadone
Treatment
Practice
Section HI (A)(1) discusses an interest in how federal opioid treatment
standards might be “modified to accommodate office based treatment.”
The Rule asks if a separate set of treatment standards should be included
in the Rule for office based treatment.
The Association has recommended that methadone treatment be offered in
office based medical practices through the vehicle of expanding access to
“medical maintenance treatment”. These recommendations have been
listed in Appendix C. These recommendations include criteria for
participating treatment programs, office based practitioners and patient
referrals.
The Association believes that stable patients should be given treatment
options, including a referral from the hub methadone treatment program to
7
an office-based practice. It is recognized that some patients many not
choose such an option, however, we believe that such options should be
made available. Medical maintenance programs currently operate in New
York State and Maryland. Research indicates that approximately seven
percent (12,530) of the existing patient population ( 179,000) would be
eligible for such medical maintenance treatment.
If the federal government agrees with the concept of expanding access to
medical maintenance treatment, the Rule should be modified to allow such
office based practitioners, which have established referral linkages from
hub methadone treatment program sites, to keep such stable patients
without meeting the burden of accreditation standards. Under this
scenario, methadone treatment programs would meet the accreditation
standards and the individual office based practice would not be required to
offer the full range of comprehensive services, which are available at the
OTP.
We understand that there is interest in providing access to treatment in
office based practices with physicians treating a number of patients, who
would be newly admitted without a referral from an existing OTP.
Current regulations allow for physicians to be involved in such practices
in areas where patients cannot get ready access to care. Our Association is
not opposed to providing access to people in need of care under such
circumstances.
Our Association does not support the policy of having physicians involved
in treating newly admitted patients, which have not been referred through
a hub referral site, where treatment is available at an OTP.
A number of critics have indicated that our Association’s Medical
Maintenance Criteria are rigid, citing international research and clinical
practices. Our Association has received conflicting information about the
success of such initiatives in Europe and Australia, Drs. John Caplehorn
and Olaf Drummer published an article in the February 1, 1999 edition of
the Medical Journal of Australia, titled “Mortality Associated with New
South Wales Methadone Programs in 1994: Lives Lost and Saved”, The
article discussed how lives were saved in preventing heroin overdose
deaths and also presented findings about methadone related deaths caused
by accidental toxicity. (The article has been attached - Appendix D.)
“Methadone was detected in postmortem material from eighty-nine New
South Wales coronial cases in 1994. These cases comprised forty-one
methadone maintenance patients (thirty-eight registered with the New
South Wales Health Department). . . .Of the thirty-eight New South Wales
maintenance patients, thirteen died in the first two weeks after admission
and twenty-five died later in treatment. We and the official pathologists
*
. . .. .
concluded that twelve of the thirteen fatalities in the first two weeks of
maintenance and six of the twenty-five deaths later in treatment were
caused by accidental toxicity. ”
The authors cited two recent British studies, from Sheffield and
Manchester, which “similarly identified significant numbers of deaths
from iatrogenic methadone toxicity early in maintenance treatment. These
problems also arose after the relaxation of admission criteria and during a
period of rapid increase in the numbers of maintenance patients and the
involvement of new, inexperienced prescribers.”
If the federal government were to certify individual physicians to provide
treatment to newly admitted opiate dependent patients and develop a
separate standard of care, a two tiered system would inevitably emerge. If
the federal government has a plan to encourage physicians to treat newly
admitted opiate dependent patients, independent of the existing OTP, then
the same standard of care should be applied. Such individual program
practitioners should be subject to the same accreditation standards as the
existing OTP.
Recommendations
for Accrediting
Small OTPS
Section VIII (L) (1) indicates that” all small programs would be required
to be accredited by an accreditation body approved by SAMHSA. Each
OTP, regardless of size would be expected to maintain this accreditation in
order to continue to treat patients.”
Section VIII (L) (2) discusses alternatives to requiring all small programs
to be accredited. “The feasibility of exempting small facilities from some
requirements will be examined.” The Association has received a number
of inquiries from small treatment programs in different states. They have
expressed great concern about discontinuing their operations since they
treat fewer than seventy-five patients at the program setting.
One of the reasons that the Association encouraged a large sample to be
included in the accreditation pilot (180 OTPS) was to incorporate a
number of such small OTPS. It is hoped that the pilot will yield
meaningful fiscal data about the needs of such programs in meeting
accreditation standards. It is certainly possible that such small operations
will be able to affiliate with other currently accredited community based
operations, however the development of a federal fi.md would assist such
programs in pursuit of accreditation.
The Association recommends that the federal agencies, which have
responsibilities for implementing accreditation, develop a series of
technical assistance documents, which will be able to assist programs with
9
different patient census sizes throughout the country. Such technical
assistance publications would serve as “how to” documents, including
model policy and procedure manuals, model diversion management plans,
model quality assurance packages in addition to other elements of the
accreditation system. Such models would be provided in a clear and
concise format, which could be specific to programs of different sizes. In
this regard, programs would not be “reinventing the wheel” many times
over throughout the United States.
Specific Recommendations
in Response to the NPRM
Quality Assurance Plans
The Association supports the intent to have OTPS develop quality
assurance plans to pursue continued improvement of patient care. Section
8.12 (C) requires such quality assurance plans and we believe that they
will improve the quality of care in the nation’s treatment programs.
Diversion Control Plans
The Association also supports the proposal of 8.12 (C) (2), “that treatment
programs include a Diversion Control Plan as part of the quality assurance
plan.” The Association’s work with the Drug Enforcement Administration
in producing a series of guidelines for improving the accountability of
methadone hydrochloride products indicates our interest in ensuring that
programs do all that they canto protect the health of the patients and the
public,
Preventing
Multiple Patient Enrollment
Section 8.12 (D) indicates that OTPS ensure that patients are not enrolled
in any other OTP upon admission. The Association recognizes that this
proposed rule retains the existing regulation. It is interesting to note that
very few states have a comprehensive computer based patient registry to
prevent such multiple enrollments. How does the Secretary propose to
implement this system where multiple patient enrollments would be
prevented?
Lifting Prohibition
on LAAM Take-Home Doses
The Rule recommends that “the Secretary has tentatively decided to
remove the prohibition on the unsupervised use of LAAM.” The
Association understands that LAAM is provided in 279 treatment
programs throughout the United States, based on the Association’s 1998
survey. LAAM has been used for a number of years in OTPS. The
Association supports removing the prohibition on the unsupervised use of
LAAM in programs since we believe that it would be of enormous help to
10
the patients. Take home use of LAAM should follow the same criteria as
proposed in option 2 for methadone take home doses.
Recommendations for Greater Clinical Flexibility for Methadone.
Take-Home Doses
The NPRM presents several options for modifying current take home
medication requirements, The Association supports the intent of
providing greater clinical flexibility in determining take home dosages for
patients, who have met the criteria of current federal law, which are
retained under the proposed rule in guiding the prescribing and dispensing
of take home medication.
The Association urges the federal government to adopt a variation within
option 2 following the Institute of Medicine recommendation. This
variation would allow individual OTPS to dispense take home supply of
medication for up to fourteen days following one year of treatment and up
to a thirty-one day supply following two years of treatment, providing the
patient has met the criteria as stipulated in the Proposed Rule,
This provision is consistent with recommendations for expanding access
to the Association’s policy on expanded medical maintenance treatment,
however, it is presumed that all such treatment decisions are made on an
individual patient basis through an organized treatment team at the
program setting and that such patients continue to access comprehensive
treatment.
SUMMARY
The Association supports the federal government’s intent to shifl
regulatory oversight away from process oriented regulations to outcome
oriented accreditation standards of care. We recommend that the federal
government develop a fund to assist a treatment program in paying for
such a shift in regulatory oversight in order to avoid a decrease in
treatment capacity. We urge the federal government not to create a two
tiered system of regulatory oversight holding OTPS accountable to
accreditation standards and individual practitioners to a different and
lesser standard of care. The development of such a two tiered system will
create instability throughout the entire system of treatment and will be
counter to the intent of the Proposed Rule.
We are hopeful that the individual states will either adopt accreditation
standards or accept the results of accreditation surveys in lieu of their own
state regulatory inspections as a means of avoiding duplication of effort
and cost. This will require extraordinary cooperation among federal
agencies and State Methadone Authorities to improve interagency
n
11
communication, which has been limited in the past. Fortunately, the
Center for Substance Abuse Treatment has been working with the State
Methadone Authorities during the past several years to improve such
interagency communication.
Our Association views the Proposed Rule as only one piece of a federal
strategy to increase access to care, to improve the quality of care currently
offered, to expand new opportunities for patients and to educate the public
about the value of methadone treatment. It moves the system to a new
place in the evolutionary chain in addiction treatment.
N!ark W. Parrino, MPA
President
nrpmdrafi
12
A
Appendix
Direcflndirect
Costs of Accredited Methadone
JCAHO/
1/99
3
E
JCAHOI
9127-29/99
----4=I
1
I $14,000.00
.,
-..
--------1
p%wmw$qf
.“ lnp::;:yia’
&#&_.,,,
outpatient drug
abuse,
child/adolescent
$17,679.00
consultantsand
staff time
Outpatient
methadone,
adolescent
alcohol/drug
abuse program
Methadone
Program and
Dug Free
$10,000.00
staff time/per
year
I
I
JCAHOI
1989
1
4
$12,363.00
$10,000.00
All drug free
and
maintenance
Methadone
outpatient,
residential,
detox, menta]
health services
Methadone, drug
free outpatient,
prevent ion,
partial hospital,
HIV early
intervention
$26,916.00
$35,000.00
staff time
comwter rrm?rade.
phy;ical plk-t and’
security upgrade
JCAHO/
10/96
Mock Survq
4
$7,400.00
.
Treatment Program,v
$7,055.00
Mental Health
Consultant (infectious control
namral) staff time
clinical supervisor
& counselor)
These data were compiled through a survey of the state provider associations, which comprise the American
Methadone Treatment Association. The information on this chart represents one methadone treatment program
within that state.
$45,000.00
hire FT staff
(Community
Psychologist)
staff time
Appendix
A (Continued)
MASSACHUSETTS
JCAHOI
1996/1999
4
$25,000.00
(multiple site fee)
Substance Abuse and
Mental Health
Service, Methadone
Program
HireQ1Director- $50k,
MIS database
Treatment satisfaction
Suweys,
Staff time
—
NEW YORK
1
------
_
4
1
1
$15,000.00
$6,000.00
Absorbed by Hospital
Article 28 Facility
Absorbed by Hospital
Substance abuse
treatment system family health centers,
ambulatory care
services
Staff time, creating
manuals, information
systems upgrade
Methadone Treatment
Staff time
Appendix
State Authority
B
Response,
September
1999
15
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Note:
The NY programs could benefit from TA concerning the development of written comprehensive policies and procedures as
wel I as providing treatment to patients with secondary addictions to other drugs such as cocaine.
.
-.
Appendix
C
Criteria for Stable Patient Referral From Methadone Programs
to Office Based Medical Practice Settings
“Expanding Access to Medical Maintenance Treatment”
I
Program Involvement:
participating agencies:
a)
b)
c)
d)
e)
II
We recommend the following criteria for choosing the
Compliance with federal and state regulatory authorities.
Adherence to CSAT’S State Methadone Treatment Guidelines and the
American Methadone Treatment Association’s Ethical Canon.
Licensed as a “Narcotic Treatment Program” for a minimum of two years.
Demonstrated internal protocols for reviewing patient eligibility, utilizing
a multidisciplinary team approach including, at a minimum, the program’s
Medical Director, Nurse Manager, and the patient’s counselor.
The program shall contract with the participating physicians.
Physician Involvement: Demonstrated interest in the treatment of opioid
dependent patients in his/her medical or psychiatric practices as defined
by:
a)
b)
c)
d)
e)
0
d
h)
i)
Certification by the American Board of Psychiatry and Neurology with
subspecialty certification in addiction psychiatry, certification by the
American Society of Addiction Medicine or Specialty Board Certification
of Physicians of the American Osteopathic Association. It is
recommended that physicians with such certification sit for a course on
opioid pharmacotherapy as offered by the American Methadone Treatment
Association or a recognized medical society.
Physicians without such certification, but with a documented two-year
involvement in a methadone treatment program, should sit for a course on
opioid pharmacotherapy as offered by the American Methadone Treatment
Association or a recognized medical society.
Knowledge of specific methadone prescribing practices as regulated by
state and federal law.
Practices consistent with CSAT’S State Methadone Treatment Guidelines.
Agreement to provide progress reports to the sponsoring “Narcotic
Treatment Program”.
Agreement to work with the patient and program regarding relapses or
unstable patients.
Provision for urine screens.
No pending state licensure actions against the participating physician.
Proof of minimum individual professional liability coverage as required
by the State Medical Board of Examiners or equivalent thereof.
III
patient EliEibili tv: The patient must meet the following criteria:
a)
b)
c)
d)
e)
be physically
and emotionally
stable for 36 months.
The patient should be free of alcohol and drug abuse for 36 months
verified by toxicology screening.
The patient has not been convicted of any criminal activity for 36 months.
The patient has been employed or in a similar capacity (a student,
homemaker or disabled) for 36 months as well as a stable living
environment.
Demonstrated responsible use of take home methadone through a
participating licensed “Narcotic Treatment Program”.
Patient
There may be exceptions granted to the 36 month criteria. Exceptions must be
based on the individual’s progress in treatment and recommendations made by the
treatment team as documented in the clinical record. The process for which this
decision can be made must be endorsed and reviewed by the State Regulatory
Authority.
IV
Organizational
1)
Professional
a)
b)
2)
b)
c)
and agency liability:
professional
liability insurance
would be
included in the physician’s file, which would be kept at the
program site.
Professional liability coverage would be incorporated into the
contractual agreement with participating physicians.
A copy of the physician’s
Methadone
a)
3)
Issues:
distribution
to participating
physicians:
The participating physicians will be registered under the umbrella
of the narcotic treatment program license.
A personnel file with resumes, license, registration numbers,
personal professional liability insurance carrier, and contract to
provide this service would be on file with the program.
The administration and dispensing of methadone hydrochloride in
an “off-site” physician based practice will require a change in
federal and state laws and regulations.
Discontinuation of off-site services: Patients will be referred back to the
base “Narcotic Treatment Program” for continued services for the
following reasons:
a)
b)
Signs and/or symptoms of recurring drug or alcohol misuse.
Negative methadone urine screens or positive for drugs not
appropriately prescribed.
c)
d)
e)
Significant changes in mental/physical/behavioral
require more patient supervision.
Noncompliance with medical care.
Evidence of criminal activity (drug or other).
(medmaexp99)
.
status that would
. .
.’
Mortality associated with New SouthWales methadone
programs in 1994: lives lost and saved
John R M Caplehorn
ethadone maintenance greatly
reduces heroin addicts’ risk of
death.’ A 15-year follow-up of
patients in New South Wales showed
methadone iiiaintenance saved lives by
reducing addicts’ risk of fatal heroin
overdose. * When combined in a metaanalysis with the results of overseas
cohort studies, the relative risk of death
in methadone maintenance was a quarter that of addicts not in treatment (g!$’%o
CI, 0. 19-0 .33).1 However, methadone
maintenance
is also a cause of death.
Patients are at risk of fatal iatrogenic
toxicity and other drug users may die
from taking methadone syrup diverted
from maintenance programs.2-s
Mortality associated with NSW maintenance programs was independently
investigated. The first report from this
project presented the case histories of
the 13 patients wh@ died in the first two
weeks of treatment.7 It identified 10
probable
cases of fatal iatrogenic
methadone
toxicity (ie, where prescribed doses of methadone
either
caused or contributed to fatal accidental drug toxicity).7 This, the second
report, presents an estimate of the relative risk of fatal accidental drug toxicity
in the first two weeks and later maintenance. It also presents estimates of the
effect of admission to methadone maintenance on the risk of fatal accidental
drug toxicity and of the number of lives
saved by NSW maintenance programs
in 1994.
M
Methods
This study was approved by the Human
Research
Ethics Committee
of the
Western Sydney Area Health Service
and the NSW State Coroner.
For editorial
comment,
Abstract
Objectives: To estimate the effects of methadone programs in New South Wales
on mortality.
Design and cases: Retrospectivej cross’-sectional study of all 1994 New South
Wales coronial cases in which methadone was detected in postmortem specimens
taken from the deceased. Cases were people we identified as patients in NSW
methadone maintenance programs or those whose deaths involved methadone syrup
diverted from maintenance programs.
C)utcorne measures: Relative risks of fatal, accidental drug toxicity in the first two
weeks of treatment and later; the number of lives lost as a result of maintenance
treatment; preadmission risks and the number of lives saved by maintenance
programs, calculated from data from a previous study.
Results: There was very close agreement between this study’s classifications and
official pathology reports of accidental drug toxicity. The relative risk (RR) of fatal
accidental drug Ioxicity for patients in the first two weeks of methadone maintenance
was 6.7 times that of heroin addicts not in treatment (950/. Cl RR, 3.3–1 3.9) and 97.8
times that of patients who had been in maintenance more than two weeks (950/. Cl
RR, 36.7–260.5). Despite 1!I people dying from ia!rogenic methadone toxicity and
diverted methadone syrup being involved in 26 fatalities. In 1994, NSW maintenance
programs are estimated to have saved 68 lives (adjusted 95% Cl, 29–1 28).
Conclusions:
In 1994, untoward events associated with NSW methadone programs
cost 36 lives in NSW. To reduce this mortality, doctors should carefully assess and
closely monitor patients being admitted to methadone maintenance and limit the use
of takeaway doses of methadone.
MJA 1999; 170:104-109
v
In late 1995 the database at the NSW
Health Department’s
Division of Analytical Laboratories
was searched to
identify 1994 coronial cases in which
methadone was detected in postmortem
specimens. ‘1’hese analytical laboratories
receive specimens
for toxicological
analysis in all cases of sudden death
referred to the NSW State Coroner.
Autopsy, toxicology and police reports
and the statements of family and friends,
prescribers
and other witnesses were
collected from coronial files.
The methadone treatment histories of
the deceased were extracted from data
see page 100
Department
of Public Health and Community
Medicine,
University
LMBBS, MPH, PhD Studenr.
John R M Caplehorn,
Medicine, Melbourne, VIC.
Victorian
Institute
of Forensic
of Sydney,
NSW.
Olaf H Drummer, PhD, Head of Scientific Services, and AssocialeProfessor,Department of
Forensic‘Medicine,MonashUniversity.
~eprints: Dr J R hi Caplehorn, Department of Public Health and Communiry Medicine, Building
A27, University of Sydney, Sydney, NSW 2006. Email: johnc@dph 1.healrh.usyd.edu.au
104
and Olaf H Drummer
held by the NSW Health Department’s
Pharmaceutical
Services Section. The
Department
also provided data on the
number of people admitted
to and
treated with methadone maintenance in
NSW in 1994.
Cases were grouped according to the
source of the methadone:
methadone
syrup given as maintenance treatment;
methadone
syrup diverted from the
maintenance program; and methadone
tablets (Physeptone; Glaxo Wellcome,
Boronia, Vie.) prescribed for pain relief.
As the Sydney black market consists
almost entirely of methadone
syrup
diverted from maintenance programs,8
illicit
drug
users
who obtained
methadone from an unknown source
were classified as having taken diverted
syrup.
We used two parallel classifications of
cause of death — that on the official
pathologist’s report, and our own. In our
MJA
Vol 170
1 February 1999
.=
. . .
RESURCH
1: A case of fatal Iatrogenlc methadone toxicity
is 1995 NSW case highlights the danger of daily doses
of 30--40 mg methadone in non-tolerant individuals and
presents a classic history of fatal iatrogenic toxicity. The
deceased had clear, early signs of methadone toxiciry:
somnolence; unsteady gait; vomiting; and a general feeling of
being unwell. The terminaI events were also typical: prolonged
coma following sleep; very slow, deep, irregular, noisy
breathin~ brown pulmonary oedema fluid coming from the
mouth or nose<
Six weeks before his death, the 19-year-old man was admitted
to hospital with hypothermia, pneumonia, right brachial plexus
neurapraxiaj rhabdomyolysis and acute renal failure after a
heroin overdose. He reported using amphetamines for six
months and heroin for two weeks. Liver tlmction test and
echocardiogram findings were normal, and at discharge three
days later his serum creatinine level had fallen from
0.18 rnrnollL to O.10rnmolL (upper normal limit, O.1232u220UIJ.
He was refereed to a short-stay, residential program and told
the admitting officer he had had problems with alcohol for five
years, cannabis for seven years and amphetamines for one year,
but had only used heroin six times. While he was considered
suitable for admission to a drug-free rehabilitation program,
this was delayed pending full recovery of his arm.
However, he was advised not to wait to enter this program
as he was facing rnal for a criminal offence. Soon after, the
deceased apparently told a general practitioner and a
methadone prescriber he k! been using heroin daily for a year.
He was prescribed 30 mg methadone, with the dose to be
increased by 5 mg every day for six days asid then reviewed.
The deceased vomited several times after receiving his second
T
\
I
I
classification,
we initially established
cause of death independently
of one
another, with one of us (OH D) blind to
the official cause of death. Cases were
first categorised as “accidental drug toxicity” and “other”. The “other” category
included suicides3 deaths from natural
causes and trauma, and deaths in which
drug toxicity was considered to have
contributed
to a death from natural
causes. The “accidental drug toxicity”
cases were further categorised
into
“methadone” and “other drug or drugs”
on the basis of whether
or not
methadone
was considered
to have
either caused or made a significant contribution to the dcatii.
There were no simple criteria for
establishing
the contribution
of
methadone
to deaths involving other
drugs. However, as deaths to which
methadone contributed
closely resembled cases of fatal methadone
toxicity,2,3,7 a relatively confident decision
cou!d be made after a thorough examiMJA
Vol 170
1 February
1999
dose (35 mg). The nexr morning, he was difficult to rouse, had
trouble walking and urinating and kept falling asleep. His father
was unable to contact the methadone prescriber, who was on
holiday, and the nurses at the prk%te methadone clinic did not
seem to have recognised the seriousness of the situation.
By late afternoon he feh much better and travelled by public
transport to receive his last dose of methadone (35 mg) at 1830.
That evening he seemed well, was in a very good mood and ate
a large dinner. However, he was still having difficul~
urinating. He went to bed at 2245. Around 0645 the next
morning his father was unable to wake him, he was breathing
deeply, noisily and imegularly and had brown fluid coming ffom
his mouth. After about ffieen minutes he stopped breathing
and died.
At autopsy, the body weighed 72 kg. No “track” or recent
injection marks could be identified. The lungs weighed 960 g
(right) and 860 g (left) and were described as “very
oedematous and congested”. The heart and liver were
macroscopicaIly and microscopically normal. The postmortem
blood methadone concentration was 0.32 m@L. No other drugs
were detected in blood, bile or urine samples. The investigating
pathologist determined the cause of death was methadone
toxicity. The Deputy NSW State Coroner dete~ed
the fatal
toxici~ was caused by the administration of three daily doses
of methadone (30 mg, 35 mg and 35 mg).13
At the inquest, the deceased’s methadone prescriber said he
did not physically examine methadone pauents and had not
rejected an applicant for maintenance in the past two years. He
routinely saw methadone patients only one day a week at a
private methadone clinic.13
nation of the documentary and toxicological
evidence
and the autopsy
report .z,’,g-[z
Police statements and photographs of
the deceased at the scene of death provided some assistance.
A brownish,
frothy oedema fluid was often observed
coming from the deceased’s mouth or
nose (see Box 1).7 Witnesses’ statements
provided a guide to likely tolerance and
chronologies
of ingestion and of the
development of symptoms and signs of
toxicity.3,7 These statements were particularly
useful in cases involving
methadone
as death usually occurred
some hours after the drug was taken, ”
and some time after the development of
coma (see Box 1).2,3,T,10~”
Postmortem
blood methadone
concentration was helpful but not definitive,
as fatal concentration
varies widely
with tolerance l’,l~ and the blood concentration of methadone increases after
death.15 Moreover,
the postmortem
increase in blood methadone concen-
tration varies unpredictably
from one
part of a cadaver to another.lb
The autopsy findings were remarkably
consistent in cases of fatal drug toxicity
involving methadone, with the immediate cause of death being pulmonary
oedema
secondary
to hypoventilation.z,i,’o!’1 As methadone toxicity USUally causes a gradually
worsening
hypoventilation, the hypoxia and resulting pulmonary hypertension are generally prolonged
and severe,
and
significant quantities of water and electrolytes, large proteins and red blood
cells leak from the pulmonary capillaries
iiito the air spaces.
consequently,
brownish
oedema
fluid
was often
observed in the large airways and the
lungs were unusually heavy (see Box 1).
Microscopic
examination
of lung specimens often showed areas of patchy
bronchopneumonia
and other evidence
of prolonged hypoventilation
and suppression of the cough reflex,2,7, L”
105
.
.
,
RESEARCH
Statistical
analysis
2: Causes of
death determined in this study and in
We used published
I
ogists concluded that 12 of
the 13 fatalities in the first
two weeks of maintenance
and six of the 25 deaths lat?r
in treatment were caused by
accidental toxicity. Three of
six deaths from accidental
drug toxicity among established maintenance
patients
were caused by heroin, one
by dextromoramide,
one by
the combined
effects
of
heroin
and dextroproxy phene,
and one involved
injected methadone syrup.
estimates
official pathologists’ reports for 38 patients in New
South Wales methadone malntanance programs and
of NSW methadone patients’
29 people whose deaths Involvad methadone divetied
risks of death after leaving
from
maintenance programs >... -:,. ,..
treatment as approximations
Accidental drug tOXiCity O~f.&
of 1994 NSW methadone
patients’ risks before admiscauses
Other
sion to treatment. 1 Rates
Methadone* drug(s)
of death
were adjusted for age, as the
Methadone maintenance patients
.
.
risk of death was signifiDeath in first two weeks
cantly higher for those aged
This study
11
1
t
20-29 years compared Wirh
10
2
1
Official report
those aged 30–39 years.’
Death after two weeks
1
This study
5
19
Weighted average risks were
1
5
19
Official report
calculated in the knowledge
Diverted methadone
that, in 1994, 68% of NSW
Diverted methadone syrup
1.2
This study
26
maintenance patients were at
2
Official report
24
3
Box 2 shows that, for the 29
least 30 years of age.17 We
Totals
cases involving
diverted
assumed half of those admit7
This study
22
38
methadone,
we concluded
ted to maintenance
were
9
23
Official report
35
methadone
contributed
m
aged 20–29 years and half
Methadone either caused or contributed to the death.
26
of
27
deaths
from
acci30–40 years.
dental drug toxicity comThe
9~’%o confidence
pared with 24 of 26 on the
intervals of mortality rates
official pathologists’ reports. One death
(4 cases), indicated the source of the
were calculated by dividing the estimates
which
we classified as accidental drug
methadone.
The
remaining
two
people
by significance factors taken from a pubtoxicity was officially attributed
t;
had professional access to methadone
lished table.ig The standard errors of the
bronchopneumonia
with methadone
tabiets and committed suicide.
relative risks were estimated using the
intoxication as a contributing factor. In
We excluded the three Queensland
binomial approximation of the Poisson
another case, we concluded injected,
maintenance patients, the neonate and
distribution. ]g
diverted melhadone
contributed
to a
all cases involving methadone tablets,
death which was officially attributed to
leaving 67 cases in the study.
Results
acute heroin poisoning.
Witnesses’
statements
or autopsy
Methadone was detected in postmortem
Methadone maintenance patients
reports indicated that methadone syrup
material from 89 NSW coronial cases in
was injected in 16 of the 26 cases we
Box 2 shows that, of the 38 NSW main1994. These
cases comprised
41
methadone
maintenance
patients (38
tenance patients, 13 died in the first two classified as accidental drug toxicity to
which diverted methadone contributed.
weeks after admission, and 25 died latel
registered
with the NSW Health
One of the IO cases involving oral ingesin treatment. We and the official patholDepartment and three with the Queensland Health Department),
one neonate
being breastfed by a NSW methadone
maintenance patient, 29 cases consid3: Rates of fatal accidental drug toxicity wad relative rkks of fatal accidental
drug toxlclty and sudden death from all causes for patients In New South
ered to have involved methadone syrup
Wales methadone maintenance programs in 1994
diverted horn the NSW methadone program, and 18 cases considered to have
Rate
Relative
involved methadone tablets.
(Deaths/1 000/yr)
risk
95% cl
In 18 of the 29 cases involving
Deaths from accidental drug toxicity
diverted methadone
syrup, either a
70.4
36.3-122.8
In first two weeks’ maintenance
bottle used to dispense
methadone
0.72.
...
0.26-1.57
After two weeks’ maintenance
..~.
syrup (5 cases), a statement from a wit6.7
3.3-.13.9
First two weeks’ maintenance v. out of treatment*
ness (10 cases), or both (3 cases), indiFirst two weeks’ maintenance v,
.. .. . .
cated that the maintenance program was
97.8
36.7~260.5
after two weeks’ maintenance
.-,
the source of the methadone.
In the
4.6-30.6
12.2
Out of treatment* v. after two weeks’ maintenance
remaining
11 cases,. it was assumed
Deaths from all causes
methadone syrup was obtained from the
3.5
2.2-5.6
Out of treatment+ v. all maintenance
black market.8 In 16 of the 18 cases
5.2
3.1-6.7
Out of treatment* v. after two weeks’ maintenance
involving methadone
tablets, either a
“ Calculated from approximations derived from previouslypublished data.
statement from the prescribing doctor (8
cases), a tablet bottle (4 cases), or both
●
I
1
I
1
r
106
MJA
Vol 170
1 February
1999
. . .
RESEARCH
1
I
tion of diverted methadone was that of
an infant who either took or was given
some of his mother’s syrup.
NSW in 1994 was 6.7 times the risk
before admission (95% CI RR, 3.3-13.9
times).
Relative risks of accidental
drug toxicity
Lives saved by NS W
maintenance programs
We concurred
The age-adjusted
with official pathologists’
conclusions that 12 paaents died of accidental drug toxicity during the first two
weeks of maintenance
treatment
in
NSW in 1994 (see Box 2). To calculate
the rate of fatal accidental drug toxicity,
we estimated the total time patients
spent in the first two weeks of maintenance treatment. In 1994, 4449 people
were admitted to methadone
maintenance in NSW. Assuming all new admissions stayed at least two weeks in
treatment, zo,zl patients spent approximately 170.5 person-years in the first
two weeks of maintenance.
Using this
estimate as the denominator, the rate of
fatal accidental drug toxicity in the first
two weeks of maintenance
was 70.4
deaths per thousand per year (Box 3).
We also agreed with official pathologists’ conclusions
that six NSW
methadone patients died from accidental drug toxicity after being in maintenance treatment for at least two weeks
(Box 2). An approximation of the total
time methadone patients spent in treatment in NSW in 1994 was derived from
the average of the number in treatment
at the beginning and end of the year
(7975 and 9038, respectively).”
The
170.5 person-years spent in the first two
weeks’ maintenance
were subtracted
from the average of the totals, 8506.5, to
estimate the total time spent in later
maintenance
— 8336 person-years.
When this was used as the denominator,
the rate of fatal accidental drug toxicity
in later maintenance was 0.72 deaths per
thousand per year (Box 3).
When combined with the previous
estimate, the risk of fatal accidental drug
toxicity in the first two weeks of treatment in NSW in 1994 was estimated to
have been 97.8 times the risk later in
maintenance (95’YoCI RR, 36.7–260.5
times). Based on the results of a previous study, ] the rate of final accidental
drug toxicity for addicts on the street
was estimated to be 10.4 per thousand
per year. Using this estimate, the risk of
fatal accidental drug toxicity in the first
two.weeks of methadone maintenance in
MJA
Vol 170
1 February
1999
approximation of the
expected
mortality
from all causes
among heroin addicts was 15.5 deaths
CI,
per thousand
per year (gs~.
11 .0–2 1.9 deaths) 1 Using this estimate, 132 deaths would have been
expected to occur in 8506.5 personCI, 93-187 deaths). As 64
years (gs~.
people either died while receiving maintenance (38) or from the toxic effects of
diverted
methadone
(26),
NSW
methadone programs are estimated to
have saved 68 lives in 1994 (95% CI,
29–1 23 lives saved). To save one life
approximately 125 patients needed to be
given methadone maintenance for a year
(95% CI, 69-293 patients).
To adjust
for possible
bias, we
assumed that up to three of the 11 cases
classified
as involving
diverted
methadone
syrup tmy have actually
involved methadone
tablets. When
added
to the two cases involving
diverted methadone
syrup in which
there were differences in the official and
study classifications of cause of death
(Box 2), the number of lives saved may
increase by up to five. Consequently, the
upper limit of the confidence interval
increased to give an adjusted 95~0 CI of
29 to 128 lives saved.
If all 10 cases of fatal iatrogenic
methadone
toxicity7 and 26 deaths to
which diverted syrup contributed had
been avoided, NSW maintenance programs would have saved 104 lives in
1994 (adjusted 95’%0CI, 65–164 lives
saved), making them up to 53?(o more
effective at saving lives (adjusted 950/0
CI, 37%-124%).
Discussion
We found that, in NSW in 1994, the risk
of fatal accidental drug toxicity in the
first two weeks of methadone maintenance was nearly seven times the risk
before admission to treatment. A previous report suggested that this excess
mortality was primarily the result of
iatrogenic methadone
toxicity. T However, the risk of fatal accidental drug
toxicity
later in maintenance
was
approximately one-hundredti
the risk in
the first two weeks of treatment and less
than one-tenth the risk before admission.
As there was complete agreement
between our classification and that of
official pathologists, our estimate of the
relative risk of fatal accidental toxicity in
the first two weeks and later maintenance is unlikely to have been significantly affected by misclassification
of
causes of death. Further, in estimating
dlat NSW methadone programs saved
68 lives in 1994, we allowed for the difference between our opinion and that of
the official report on the role of diverted
methadone in two cases when calculating the upper limit of the adjusted 95~0
confidence interval (29–1 28) for the
number of lives saved by NSW maintenance programs.
Another consideration
in estimating
the number of lives saved is that mortality among patients discharged from
maintenance is only an approximation of
preadmission risk. If the real risk on the
streets was higher than our estimate,
NSW methadone programs would have
saved more lives and admission
to
maintenance
would not have caused
such a dramatic increase in the risk of
fatal accidental
drug toxicity. Conversely, if the real risk was lower, the
reverse applies.
Our estimates of the number of lives
saved and the increase in the risk of fatal
accidental drug toxicity associated with
admission to maintenance are approximations only. However, as our estimated
71 Y. reduction in mortality is very similar to that observed in the US during
the early 1970s, in Sweden during the
1980s, in Germany in the 1990s and
Australia during the 1970s and 1980s,’
they are probably reasonably accurate.
Previous Australian studies have also
identified
mortality
associated
with
methadone programs. Eighteen people
died from methadone toxicity in Western Australia in the years 1975 to
1980. However, there were virtually no
such deaths after WA maintenance
patients were required to take their
methadone
under supervision. zJ In
South Australia,
nine maintenance
patients died from drug toxicity in the
years 1984 to 1994, while 12 other
people died from the toxic effects of
107
---
RESEARCH
I
diverted
methadone
syrup. zz The
number of deaths per 1000 SA maintenance patients was approximately 75°/0
of that observed in our study. Our finding that diverted methadone syrup contributed to 26 deaths in NSW in 1994 is
supported by the results of a previous
investigation
which suggested
that
diverted methadone syrup was involved
in up to 100 deaths between July 1990
and December 1995.6
The WA experiencez~ suggests the
number
of deaths
from diverted
methadone
syrup is related
to the
number of takeaway doses dispensed to
maintenance
patients for consumption
on subsequent days. In 1994, two-thirds
of private sector patients received four
takeaway doses a week, with some programs giving five or six a week to newly
admitted patients.zg Although the NSW
Health Department argued against such
practices, there was no policy enforcement.z~ To minimise the diversion of
methadone
syrup from maintenance
programs, the NSW Health Department
shollld monitor and ensure compliance
with its current policy which strictly
limits the number of takeaway doses
available to recent admissions
while
giving stable, long-term patients access
to generous takeaway privileges.
A serious problem with iatrogenic
methadone
toxicity was identified in
Victoria, where 10 deaths occurred
among newly admitted
methadone
patients in the last six months of 1989.2
As Victorian
methadone
programs
treated fewer than 1200 maintenance
patients in this period, the rate of iatrogenic methadone
toxicity was many
times that observed in our study. It is
noteworthy
that, during
1989, the
number
of Victorian
maintenance
patients and programs increased rapidly
and a number of inexperienced
and
poorly trained prescribers entered the
field.z,3 Persons with minimal or no tolerance were prescribed
initial, daily
methadone
doses of 50–70 mg, with
fatal results.z
Two recent British studies,
from
Sheffield and Manchester,
have similarly identified significant numbers of
deaths from iatrogenic methadone toxicity early in maintenance treatment.4’5
These problems also arose after the
relaxation
of admission
criteria and
during a period of rapid increase in the
108
numbers of maintenance
patients and
We recommend prescribers be made
the involvement of new, inexperienced
aware of the risks, signs and symptoms
prescribers.~,s
of methadone toxicity and be required to
examine newly admitted patients every
While the official criteria for admisday for the first one to two weeks of
sion to methadone
maintenance
in
NSW have not changed since 1988,25 maintenance. People seeking methadone
they were not being implemented
in maintenance should be required to give
written consent after being warned
1994.26 Statements made by its Chairabout the dangers of misleading their
man in 1996 indicate that the NSW
doctor
and of the use of other drugs,
Medical Committee had not been applyparticularly
benzodiazepines
.T,Jl We
ing the official admission criteria for
believe that the forthcoming
N.SW’
some time.zs This is significant because,
methadon; maintenance treatment Ji;zical
under the NSW Poisons Act, the Medpractice guidelines will address these
ical Committee advises the NSW Health
issues.
Department
on applications from docWe strongly recommend
the estabtors to prescribe methadone
maintelishment of independent,
expert comnance to addicts.
mittees to investigate methadone-related
There were also problems with predeaths in States and Territories with
scriber training. Since 1993, the NSW
maintenance
programs.
These comMethadone
Prescribers’ Accreditation
mittees should be modelled on those
Program has used the ivfethadone preanaesthesia-related
scribers’ manual as its course material. z’ used to monitor
deaths.
Contrary to NSW Health Department
states heroin
policy,25 the “Manual”
users need not have a history of physiAcknowledgements
ological dependence
on opioids to be
eligible for maintenance treatment.2b’27
For their advice and generous assistance,we thank the
NSWState Coroneral Glebe, the WestmeadCoUrl the
We urge the NSW Health Department
Dlvislonof AnalyticalLaboralor:es,andthePharrnaceLt.cal
to revise its Methadone
prescribers’
sewices Branchof the NSWHealth Department, and the
mattual,27 review prescriber
training
Drugs of Dependence
Unit, Queensland
Hea!th Deparimenl. We also thank Professor
Geoffrey
Berry of [he
and to ensure compliance with its curDepartment
of Public Health and Communiry
Mecicine,
rent admission
criteria for mainteUnwersity of Sydney, who assisted with the statistics and
presentation
of results.
nance treatment.2s,2s
In 1994, Victorian and Queensland
methadone prescribers were required to
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Gordon
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intern working in Perth (Western Australia) in the late 1970s, I was struck by the different impact made by two eminent medical pioneers who
simultaneously visited our remote shores. Jonas Salk —
whose polio vaccine was responsible for the eradication
of that disease in the United States — received little
media attention,
giving only the occasional
radio
interview, while Christian Barnard — the first surgeon
to transplant a human heart — was the focus of intense
media attention, with staged newspaper pictures and
television coverage wherever he went. Indeed, the public
health impact of vaccines, and the molecular miracles of
modern vaccine biology, are still mostly taken for
granted by the community.
So it is timely that two highly qualified authors, Ada
and Ramsay, take us on a scholarly walk through some
of these achievements and bring us up-to-date with current developments in “vaccinology”. We learn that there
are more than 300 vaccines in the pipeline, mostly
directed towards infectious agents. The authors eloquently describe the increasing role of immunologists in
vaccine design, while emphasizing the importance of
innate immunity in vaccine success. The need for nonspecific inflammatory danger signals to elicit immunity
(immunology’s “dirty little secret”) ensures that adju-
1999
Pub!Ic Health
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28
atti-
Transcript
s a young
Vol 170
JB, Physicians’
n New south Wafes, Aus-
Bell J, O’Connor D. Methadone
prescribers’
manual.
Sydney. NSW Heakh Department,
1993:11,23
methadone
(xii + 247 pp., $161). ISBN: 0-397-58761-9.
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traha [Iet!er]. Drug ,AlcOho/ Rev 1998
DG. Clinic
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JRM, Inwg L, Saunders
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DR, Kleinbaum
in methadone
24
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McNeil
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JE. She depenconcentra-
for methadone
1994.
27
Dependence
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in medical
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Swensen G. Optoid drug deaths In Western Australia
1974-1984
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drug redistribu-
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18 Ott
1998)
3
vants, cytokines, delivery vehicles and live vaccines are
still high on the agenda of vaccine science. (The potency
of an immune response depends upon the level of nonspecific inflammation,
which in turn helps activate lymphocytes. The dirtier the wound, the more vigorous the
response; this is immunology’s
“dirty little secret” — a
well-known phrase in immunology.)
Recombinant
proteins, engineered peptides and naked DNA vaccines are
discussed in enough detail to enhance the book’s usefulness to those interested
in infectious
disease and
public health.
The authors write objectively about vaccine safety, an
extremely important
issue for all of us, highlighted
by
some exaggerated
claims concerning side effects of the
current whole-cell pertussis vaccine. Perhaps vaccine science might finally capture the public imagination
as we
enter a period of intense activity to develop vaccines
against tumours, allergies and autoimmune
diseases
such as diabetes. A vaccine with efficacy against any of
these conditions would have an enormous impact on
healthcare expenditure. Just imagine how many more
heart transplants we could carry out with the extra
money saved.
At $161 the book is a little expensive for individuals,
but it is worth requesting through your local medical
library.
James
Professor
of Mlcrobiofogy
University
of Melbourne,
McCluskey
and Immunology
Melbourne
VIC
109